Cochlear Implant Low Power Strategy

Clinical Assessment of a Low Power Strategy for Cochlear Implant Recipients

Reducing power consumption in the cochlear implant is crucial to the development of future smaller sound processors. The commercial MP3000 sound coding strategy has been shown to be more efficient in power consumption to the standard ACE strategy. However in order to develop smaller sound processors, further battery life power savings are required. The aim of this study is to evaluate three experimental sets of MP3000 parameter sets, compared against the default ACE program. In the background for each of the four strategies, experimental noise reduction programs (SpatialNR and NR3) will also be in use. In an additional phase of the study, low stimulation rate ACE programs will also be evaluated against the default stimulation rate.

Study Overview

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • The HEARing CRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult (>18 years) cochlear implant recipients
  2. Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.
  3. User of commercially available Freedom, CP810 or CP900 series sound processor
  4. User of the ACE strategy or MP3000 strategy
  5. At least 3 months experience with the cochlear implant
  6. Native speaker in the language used to assess speech perception performance
  7. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

  1. Additional handicaps that would prevent participation in evaluations
  2. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MP3000-ACE strategy
MP3000 sound coding strategy or ACE strategy with lower stimulation rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Word recognition scores in quiet
Time Frame: Testing over 18 weeks
Word recognition scores in quiet for i) MP3000 strategy compared to default ACE strategy and ii) lower rate stimulation for ACE strategy
Testing over 18 weeks
Sentence recognition scores in quiet
Time Frame: Testing over 18 weeks
Sentence recognition scores in quiet for i) MP3000 strategy compared to ACE strategy and ii) lower rate stimulation for ACE strategy
Testing over 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fundamental frequency (F0) discrimination
Time Frame: Testing over 18 weeks
F0 discrimination for MP3000 strategy compared to the ACE baseline
Testing over 18 weeks
Speech intelligibility and helpfulness subjective ratings
Time Frame: Testing over 18 weeks
For MP3000 strategy compared to the default ACE baseline
Testing over 18 weeks
Sentence in noise scores
Time Frame: Testing over 18 weeks
Comparison of MP3000 program with Spatial NR and NR3 enabled versus disabled.
Testing over 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2015

Primary Completion (Actual)

January 27, 2017

Study Completion (Actual)

January 27, 2017

Study Registration Dates

First Submitted

August 21, 2016

First Submitted That Met QC Criteria

August 21, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

July 6, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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